The validation engineer will primarily be responsible for developing, maintaining and improving a standardised validation process for the Plant to ensure compliance to required regulations within the engineering function. Participate as part of project team to ensure all validation requirements are met in accordance with project management procedures.

Responsibilities:

Drive the engineering validation function in conjunction relevant departments i.e. QA/RA in the development and provisions of documentation for the qualification (IQ/OQ/PQ) related to agreed Plant validations.

Working as a member of the engineering project team to review what projects require validation.

Assist with URS development for software validation projects.

Interact with other departments conducting the validations before protocols are written and again to review the validation data for the validation report.

Ensure that all data, results and information associated with qualification and validation data provided for reports are in accordance with written procedures.

Validation documentation;

Implement, deploy and revise as applicable all Validation procedures.

Development and maintenance of Validation Master Plans and Validation Strategies.

Ensure that the plant master validation list is kept up to date and that approved records for all the validations listed and available in hard copy for audits.

Writing and arranging approval of validation protocols and reports;

Update validation protocol/reports with deviations report.

Ensure continued compliance with all Regulatory Standards. This includes: